General MedicationsORALStandard
DEXLANSOPRAZOLE
DEXLANSOPRAZOLE
Standard Dose
60MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview DEXLANSOPRAZOLE is listed in Drugs@FDA under application 219115 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient DEXLANSOPRAZOLE Form and strength CAPSULE, DELAYED RELEASE;ORAL - 60MG Sponsor ALEMBIC Submission history Latest submission status date: 2025-11-12 00:00:00.
Structured Monograph
Clinical summary
Approval overview DEXLANSOPRAZOLE is listed in Drugs@FDA under application 219115 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DEXLANSOPRAZOLE Form and strength CAPSULE, DELAYED RELEASE;ORAL - 60MG Sponsor ALEMBIC Submission history Latest submission status date: 2025-11-12 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.